RecruitingNCT06394739
RevCore for In Stent Thrombosis
RevCore for In Stent Thrombosis (REVIT)
Sponsor
Inari Medical
Enrollment
100 participants
Start Date
Sep 9, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
The purpose of this research is to collect information about how the RevCore Thrombectomy Catheter works to treat stent blockages.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- Age ≥ 18 years
- Patients with stent age > 6 weeks
- Location of thrombosed stents in proximal lower extremity deep vein segments including at least common femoral, external iliac, or common iliac vein
- RevCore Thrombectomy Catheter must enter vasculature
- Willing and able to provide informed consent
Exclusion Criteria12
- Exposed stents with broken struts, significantly deformed struts, struts protruding into the vessel
- Stents not wall apposed
- Stents compressed to <10mm
- Bilateral in-stent thrombosis
- Congenital anatomic anomalies of the iliac veins
- Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast agents, except for mild to moderate contrast allergies for which pretreatment can be used
- Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period
- Chronic non-ambulatory status
- Known hypercoagulable states (e.g. antiphospholipid syndrome) that, in the opinion of the Investigator, cannot be medically managed throughout the study period
- Inability to secure venous access
- Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
- Current participation in another investigational drug or device treatment study
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Interventions
DEVICEThrombectomy
RevCore Thrombectomy to treat in-stent thrombosis
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT06394739